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Showing 4561–4580 of 22534 results

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Breg Walker (Breg) – Misaligned Wheels (2023)

Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.

FDASep 13, 2023AL, AZ, AR +38 more• Breg Inc

Monoject Tuberculin Syringe (Cardinal Health) – Tip Compatibility (2023)

Syringe contains conical tip that is not compatible with certain needleless IV connector(s).

FDASep 13, 2023Nationwide• Cardinal Health 200, LLC

Maquet Acrobat-i Stabilizer (Maquet) – Housing Mount Failure (2023)

Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.

High

FDASep 13, 2023Nationwide• Maquet Cardiovascular, LLC

RayCare (RaySearch) – Document Visibility Issue (2023)

An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.

FDASep 12, 2023MD, TN• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

BACTEC Culture Vials (Becton Dickinson) – Barcode Duplication (2023)

Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

FDASep 12, 2023Nationwide• Becton Dickinson & Co.

Cios Alpha C-arm (Siemens) – Software Update (2023)

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

FDASep 12, 2023Nationwide• Siemens Medical Solutions USA, Inc

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

DxI 9000 Analyzer (Beckman Coulter) – Barcode Presentation (2023)

The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

FDASep 12, 2023Nationwide• Beckman Coulter, Inc.

VITROS Lipase Slides (Ortho-Clinical) – Result Bias (2023)

Laceration Risk

Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

FDASep 12, 2023CA, CO, FL +9 more• Ortho-Clinical Diagnostics, INc.

Cios Flow C-arm (Siemens) – Software Update (2023)

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

FDASep 12, 2023Nationwide• Siemens Medical Solutions USA, Inc

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

Burn Pack (ROi CPS) – Dermatome Blade Issue (2023)

Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.

FDASep 11, 2023MO• ROi CPS LLC

Spetzler-Malis Forceps (Stryker) – Expiration Labeling (2023)

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

FDASep 11, 2023Nationwide• Stryker Corporation

Sapphire Infusion Pumps (Eitan Medical) – Air Detection Failure (2023)

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

FDASep 11, 2023Nationwide• EITAN MEDICAL LTD 29, Yad Kharutsim Netanya Israel

Omega Monitor Suspension (Omega Medical) – Boom Detachment (2023)

An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.

FDASep 8, 2023AL, CA, IL +8 more• Omega Medical Imaging, Inc.

Centricity Viewer Workflow Manager (GE Healthcare) – Exam Launch Issue (2023)

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

FDASep 8, 2023Nationwide• GE Healthcare

Universal Viewer Workflow Manager (GE Healthcare) – Exam Launch Issue (2023)

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

FDASep 8, 2023Nationwide• GE Healthcare

F2-01 Patient Monitor (GE Medical) – Data Communication Interruption (2023)

There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

FDASep 8, 2023Nationwide• GE Medical Systems China Co., Ltd. National Hi-Tech No.

CORI RI.KNEE Software (Blue Belt) – Planning Stage Missing (2023)

CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis

FDASep 7, 2023Nationwide• Blue Belt Technologies, Inc

Alcon Custom-Pak (Alcon) – Latex Mislabeling (2023)

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

FDASep 7, 2023VA• Alcon Research, LLC

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